Therapeutic Equivalence (TE) Study of Propofol 2% MCT Fresenius (MCT=Medium-Chain Triglycerides) Compared With Diprivan® in Patients Undergoing Elective Surgery

NCT ID: NCT01856998

Last Updated: 2014-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31

Brief Summary

The purpose of this study is to evaluate the therapeutic equivalence, based on pharmacodynamic parameters of Propofol 2% (20 mg/mL) MCT Fresenius and Diprivan® 20 mg/mL (AstraZeneca), administered by target controlled infusion (TCI).

Conditions

General Anesthesia; Elective Surgery

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Diprivan® 20 mg/mL (AstraZeneca)

Dosage form: lipid emulsion

Dosage: Initial effect-site target concentration: 5 μg/mL, if necessary increased by 1 μg/mL every 60 seconds until LOER

Frequency: continuously (will be adjusted to keep Bispectral Index (BIS) between 40 and 60, however maintenance target concentration can be increased if a patient needs a BIS <40 with regard to individual condition and the respective surgery)

Duration: Until end of surgery

Group Type: ACTIVE_COMPARATOR

Diprivan

Intervention Type: DRUG

Propofol 2% (20 mg/mL) MCT Fresenius

Dosage form: lipid emulsion

Dosage: Initial effect-site target concentration: 5 μg/mL, if necessary increased by 1 μg/mL every 60 seconds until LOER

Frequency: continuously (will be adjusted to keep Bispectral Index (BIS) between 40 and 60, however maintenance target concentration can be increased if a patient needs a BIS <40 with regard to individual condition and the respective surgery)

Duration: Until end of surgery

Group Type: EXPERIMENTAL

Propofol

Intervention Type: DRUG

Interventions

Propofol

Intervention Type: DRUG

Diprivan

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects ≥18 years and <65 years old

2. Able to understand and give signed and dated written informed consent

3. Body mass index (BMI) ≥20 and ≤30 kg/m² at screening

4. ASA (American Society of Anesthesiologists) physical status 1 or 2

5. Undergoing elective, minor orthopedic, vascular, urological, or gynecological surgery

6. Patients should be affiliated to a social security scheme and benefit from the corresponding rights and cover

Exclusion Criteria

1. The following planned procedures are to be excluded:

• Day surgery
• Emergency surgery
• Total hip or total knee replacement
• Requiring opening of the great cavities of the body (cranium, thorax, peritoneum, or pelvis)
• With routine risk, even if low, of hemorrhage severe enough to require administration of colloid or blood products
• With routine risk, even if low, of death during or soon after the procedure
• Vascular surgery involving the aorta, venae cavae, iliac arteries, or femoral arteries

2. Intended administration of IV medications through a central venous catheter (Note: a central venous catheter may be used to obtain Pharmacokinetic (PK) samples, though only if no port of the catheter is being used for administration of any other product, including crystalloid infusion at more than a "keep line open" rate)

3. Administration of general anesthesia or propofol within the 7 days prior to randomization

4. History of hypersensitivity to propofol, eggs, soya, peanuts, or any other constituent of the study drugs

5. ASA physical status ≥3

6. History of major anesthesia complications including, but not limited to:

• Clinically significant hypoxia
• Profound hypotension
• Anaphylaxis or anaphylactic reactions
• Unpredictable anesthesia agent requirements

7. History of difficult airway management including, but not limited to:

• Problematic artificial ventilation with face mask
• Repeated difficulty of placement of laryngeal mask airway (LMA)
• Difficult laryngeal intubation (Cormack-Lehane grade 3 to 4) and requiring alternative technique e.g. fibre-optic or awake laryngeal intubation

8. History of difficult venous access

9. Myocardial infarction within 6 months of randomization or a cardiac reperfusion procedure within 6 weeks of randomization

10. Significant respiratory, cardiovascular, liver or renal disease as assessed by investigator

11. Active systemic infection (localized infection related to surgical procedure is allowable as long as there is no indication of systemic involvement)

12. History of psychiatric disorder, including use of sedatives or antidepressants for any reason, within 6 months prior to randomization

13. Alcohol or other substance abuse within 2 years prior to randomization, as well as for the duration of the study

14. Use of medication that could reduce the subject's respiratory and/or cardiac output

15. Female subjects who are pregnant, breastfeeding, or lactating

16. Hemoglobin <7.5 g/dL at screening or randomization

17. Platelets <50,000 x 10³/μL at screening or randomization

18. ECG findings detected at screening not consistent with the subject's medical history or warranting cardiology review

19. Participation in an interventional clinical study within 6 months of screening

20. History of Propofol infusion syndrome

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

Fresenius Kabi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francois Sztark, Professor

Role: PRINCIPAL_INVESTIGATOR

CHU de Bordeaux, Groupe Hospitalier Pellegrin

Locations

CHU de Bordeaux, Groupe Hospitalier Pellegrin

Bordeaux, , France

Countries

France

Other Identifiers

2012-005701-43

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PROP-001-CP3

Identifier Type: -

Identifier Source: org_study_id